Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure is developed in China for vaginal apex fixation with native tissue.

This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure for the treatment of pelvic organ prolapse stage III.

Patients enrolled into the study will be followed up for up to 3 years after surgery. Evaluation will take place during surgery and postoperative visit. Stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.

Anatomical improvement according to POP-Q Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Anatomical improvement according to POP-Q Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Anatomical improvement according to POP-Q Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hospital data including operative time, estimated blood loss, length of stay, postoperative mortality, time of voiding recovery [ Time Frame: At discharge, an expected average of 5 days after operation ] [ Designated as safety issue: Yes ]

The occurrence (in the per-operative phase or within 6 weeks post-op) of at least one of the following: 1) bleeding complications; 2) infectious complications; 3) any wound caused by a surgeon movement: bladder, ureteral, or vascular injuries; 4)medical complications: deep vein thrombosis, pulmonary embolism and etc.Complications will be categorized using the Dindo surgical complication grading scale

Change from baseline in PFIQ-7 scores [ Time Frame: 6 month, 1 year, 2 years and 3 years ] [ Designated as safety issue: No ]

Presence/absence of complications (composite score) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Long-term negative outcomes of the surgical procedure will also be recorded until 3 years after surgery. For example, de novo urinary incontinence, de novo dyspareunia and overall failure rate. Complications will be categorized using the Dindo surgical complication grading scale.

Ischia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse.

Detailed Description:

Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. An ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function.

Ischia spinous fascia fixation procedure is developed in China. It is a transvaginal procedure used for restoring the vaginal apex support with native tissue. Clinical practice showed that it was safe, efficient and cost-effective. Recurrent rate after 1 year follow-up was about 10%, and quality of life improved significantly from the baseline.

The purpose of this multicenter, prospective study is to evaluate the effectiveness and safety of this procedure in the treatment of symptomatic pelvic organ prolapse.

In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01760603